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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02349490
Other study ID # Seraseal1
Secondary ID
Status Completed
Phase Phase 4
First received January 18, 2015
Last updated January 23, 2015
Start date November 2011
Est. completion date January 2015

Study information

Verified date January 2015
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food Safety
Study type Interventional

Clinical Trial Summary

Patients with active gastrointestinal bleeding can be included. 5ml of SerasealTM/Fastact (Wortham Laboratories, Chattanooga, USA), a CE-certified medical product for in human intraoperative use as hemostatic agent, is topically applied via catheters to the bleeding site. In group A, Seraseal is applied as initial method for hemostasis. In group B, Seraseal is applied after an initial failure of the institutional standard method. Homeostatic success is determined by 5 min without bleeding at gastrointestinal site. after application of Seraseal.


Description:

Following endoscopic confirmation of a bleeding, 2,5-5ml of liquid Seraseal / Fastact, certified for intraoperative use in humans (CE No 0653), is topically applied to the bleeding site. The delivery device consisted of a 5ml syringe containing Seraseal plugged to standard delivery catheters, either ERCP catheters or dye spraying catheters (Boston Scientific, USA) that are inserted via the working channel of the endoscope. Once the bleeding is identified at endoscopy, the delivery catheter is inserted through the endoscope and positioned toward the lesion, leaving 1-2 cm between the bleeding site and the catheter tip. Seraseal is then delivered in short spray bursts or direct shots (for 1-2 seconds) until hemostasis is confirmed. A maximum of 5ml of Seraseal is administered in each patient. Homeostatic success is determined by 5 min without bleeding at gastrointestinal site. after application of Seraseal.

Two groups are formed for analysis of this proof of concept study:

In group A, Seraseal is applied as initial method for hemostasis. If successful, the bleeding site is then observed for 5 minutes. If bleeding remains active or recurs, the institutional standard of care for hemostasis is applied.

In group B, Seraseal is applied as rescue therapy after an initial failure of the institutional standard method. If Seraseal is successful, the bleeding site is then observed for 5 minutes. If the bleeding remains active or recurs after Seraseal, alternative methods of hemostasis will be applied.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date January 2015
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- active gastrointestinal hemorrhage

Exclusion Criteria:

- no sign of active bleeding at endoscopy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Seraseal / Fastact Hemostatic agent (combined activated factors IIa, VIIa, IXa, Xa )
Following endoscopic confirmation of a bleeding, 2,5-5ml of liquid Seraseal / Fastact, is topically applied to the bleeding site via catheter

Locations

Country Name City State
Austria KH der Elisabethinen Linz Linz Oberoesterreich
Austria Division of Gastroenterology, Medical University of Vienna Vienna
Austria Rudolfstiftung Vienna
Germany Hannover Medical School Hannover

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hemostasis Success (=Hemostasis) for 5 minutes after Seraseal application 5min No
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